Microbiological contamination models for use\ud in risk assessment during pharmaceutical\ud production

Article English OPEN
Whyte, W. ; Eaton, T. (2004)
  • Publisher: Euromed Communications Ltd.

This paper describes the fundamental mechanisms of microbial contamination during manufacture\ud of pharmaceutical products. Models are derived that describe air and surface contact contamination.\ud These models can be used to develop and improve methods of microbial risk assessment. The use of\ud the FMEA (FMECA) method of risk assessment is discussed and, when used with the correct risk\ud factors, its use endorsed.
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